The following data is part of a premarket notification filed by The Binding Site with the FDA for Human Iga Liquid Reagent Kit For Use On Spa Plus.
| Device ID | K103824 |
| 510k Number | K103824 |
| Device Name: | HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUS |
| Classification | Method, Nephelometric, Immunoglobulins (g, A, M) |
| Applicant | THE BINDING SITE PO BOX 11712 Birmingham, GB B14 4zb |
| Contact | Suzanne Horne |
| Correspondent | Suzanne Horne THE BINDING SITE PO BOX 11712 Birmingham, GB B14 4zb |
| Product Code | CFN |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-30 |
| Decision Date | 2012-02-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05051700016742 | K103824 | 000 |
| 05051700012232 | K103824 | 000 |